NL-OMON45889招募中不适用
CALM-DIEM_EUR - Controlling and Lowering Blood Pressure with the MobiusHD* - Defining Efficacy Markers ;CALM-DIEM_EUR Sub-study - Studying the Effect of the MobiusHDTM on Sympathetic Activity and Baroreflex Sensitivity;CALM-DIEM_HTN-HF Sub-study - Studying the Effect of the MobiusHD® System in Hypertensive Patients with mild Chronic Heart Failure - CALM-DIEM_EUR;CALM-DIEM_EUR Sub-study;CALM-DIEM_HTN-HF Sub-study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 39
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. >= 18 years of age and <= 80 years of age;
- •2. Diagnosed with primary resistant hypertension;
- •3. Mean 24-hour systolic ABPM is >=130 mmHg following at least 30 days on a
- •stable anti-hypertensive medication regimen (no changes in medication or dose)
- •and no more than 7 days prior to implantation.For the sub-study:
- •1. Eligible for the CALM-DIEM Study and having passed all CALM-DIEM Study
- •inclusion and exclusion criteria at CALM-DIEM Study ScreeningFor the HF
- •sub-study:
- •1. Eligible for the CALM-DIEM Study and having passed all CALM-DIEM Study
- •inclusion and exclusion criteria at CALM-DIEM Study Screening
- •2. Mild to moderate chronic heart failure (New York Heart Association
- •(NYHA) Class II or III)ndefined
排除标准
- •1. An inability provide written informed consent.
- •2. Known or clinically suspected baroreflex failure or autonomic neuropathy.
- •3. Known significant aortoiliac or common femoral artery disease that will
- •prohibit safe femoral access.
- •4. Hypertension secondary to an identifiable and treatable cause other than
- •sleep apnea (e.g., hyperaldosteronism, renal artery stenosis, pheochromocytoma,
- •Cushing's disease, co-arctation of the aorta, hyperparathyroidism and
- •intracranial tumor).
- •5. Treatable cause of resistant hypertension including, but not limited to,
- •improper BP measurement, volume overload and pseudotolerance (excessive sodium
- •intake, volume retention from kidney disease, inadequate diuretic therapy),
- •drug-induced or other causes (non-adherence, inadequate doses, inappropriate
- •combinations, NSAIDs, COX-2 inhibitors, cocaine, amphetamines, or other drugs,
- •sympathomimetics, oral contraceptives (confirmed cause of resistant
- •hypertension), adrenal steroids, cyclosporine, and tacrolimus, erythropoietin ,
- •licorice (including some chewing tobacco), ephedra, ma haung, bitter orange);
- •and excessive alcohol intake.
- •6. Arm circumference greater than 46 cm and/or BMI >= 45.
- •7. Chronic atrial fibrillation or recurrent atrial fibrillation with episode
- •within the last twelve (12) months.
- •8. History of bleeding complications with dual antiplatelet therapy in the past
- •or has known uncorrectable bleeding diathesis.
- •9. Current use of anticoagulation therapy, other than dual antiplatelet
- •medications. Examples include vitamin K antagonists and novel oral
- •anticoagulants including apixaban, rivaroxaban, dabigatran etexilate and
- •10. Peptic ulcer disease with documented active ulcer or bleeding within the
- •11. History of allergy to contrast media that cannot be managed medically.
- •12. Persistent symptomatic orthostatic hypotension (>20/10 mmHg).
- •13. Persistent symptomatic syncope documented to be related to hypertension
- •within the last six (6) months.
- •14. History of myocardial infarction or unstable angina within the past three
- •(3) months.
- •15. History of cerebral vascular accident (stroke or TIA) within the past year,
- •and NIHSS >5 or mRs >1.
- •16. Chronic kidney disease (GFR calculated by the Modification of Diet in Renal
- •Disease equation < 45 ml/min).
- •17. Prior carotid surgery, radiation, or endovascular stent placement in either
- •carotid region.
- •18. Severe valvular or structural heart disease (excluding LV hypertrophy).
- •19. Severe chronic obstructive pulmonary disease (requiring twenty-four-hour
- •oxygen or oral steroids), asthma, or severe pulmonary hypertension.
- •20. Uncontrolled diabetes mellitus with HbA1c >= 10 %.
- •21. Active infection within the last month requiring antibiotics.
- •22. Uncontrolled co-morbid medical condition, including mental health issues,
- •that would adversely affect participation in the trial.
- •23. Co-morbid condition that reduces life expectancy to less than one (1) year.
- •24. Planned surgery or other procedure within the next six (6) months requiring
- •cessation of antiplatelet medications.
- •25. Pregnant or lactating females. For females of child-bearing potential, a
- •positive pregnancy test within seven (7) days of the pre-randomization
- 另有 2 项未显示
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